Infrared Coagulator Ablation or Observation in Preventing Anal Cancer in HIV-Positive Patients With Anal Neoplasia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
AIDS Malignancy Clinical Trials Consortium
ClinicalTrials.gov Identifier:
NCT01164722
First received: July 16, 2010
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

RATIONALE: Infrared coagulator ablation may be effective in preventing the development of anal cancer in patients with anal neoplasia

PURPOSE: This randomized phase III trial is studying infrared coagulator ablation to see how well it works compared to observation in preventing anal cancer in HIV-positive patients with anal neoplasia.


Condition Intervention Phase
Anal Cancer
Neoplasm of Uncertain Malignant Potential
Nonneoplastic Condition
Precancerous Condition
Other: clinical observation
Procedure: infrared photocoagulation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Randomized Clinical Trial of Infrared Coagulator (IRC) Ablation Versus Expectant Management of Intra-Anal High Grade Intraepithelial Neoplasia (HGAIN) in HIV-infected Adults

Resource links provided by NLM:


Further study details as provided by AIDS Malignancy Clinical Trials Consortium:

Primary Outcome Measures:
  • Complete response at 3 months and 1 year [ Time Frame: 3 months and 1 year post treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tolerability and safety of infrared coagulator ablation [ Time Frame: All study visits through year 2 ] [ Designated as safety issue: Yes ]
  • Proportion of patients with high-grade anal intraepithelial neoplasia at 1 year [ Time Frame: 1 year on study ] [ Designated as safety issue: No ]
  • Recurrence rate at 1 year [ Time Frame: 1 year on study ] [ Designated as safety issue: No ]
  • Incidence of metachronous lesions [ Time Frame: every 3 months on study ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: April 2011
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Infrared coagulator (IRC) contact tip is placed in direct contact with lesion under high-resolution anoscopy (HRA) guidance. Patients then undergo IRC ablation for 1.5 second pulses. IRC ablation is reapplied until the level of submucosal vessels are reached.
Procedure: infrared photocoagulation therapy
Anal infrared coagulator ablation
Active Comparator: Arm II
Patients receive standard of care and undergo observation. After 12 months, patients may receive IRC ablation to all anal intraepithelial neoplasia lesions despite of their size.
Other: clinical observation
Patients undergo observation

Detailed Description:

OBJECTIVES:

Primary

  • Evaluate the complete response rate at 3 months and 1 year in HIV-seropositive patients with high-grade anal intraepithelial neoplasia (HGAIN) treated with infrared coagulator (IRC) ablation versus observation.

Secondary

  • Determine the tolerability and safety of IRC ablation versus observation in these patients.
  • Compare the proportion of patients with HGAIN at 1 year.
  • Evaluate the response and recurrence rates at 1 year of individual lesions in patients treated with this regimen vs observation.
  • Determine the incidence of metachronous lesions in these patients.
  • Compare the response and recurrence rates at 2 years of individual lesions in patients under observation who subsequently received IRC ablation with the response and recurrence rates at 1 year in patients initially treated with IRC.

OUTLINE: This is a multicenter study. Patients are stratified according to site. Patients are randomized to 1 of 2 arms.

  • Arm I: Infrared coagulator (IRC) contact tip is placed in direct contact with lesion under high-resolution anoscopy (HRA) guidance for 1.5 seconds. IRC ablation is reapplied until the level of submucosal vessels are reached.

    • One week after each IRC ablation, patients complete a questionnaire regarding pain, bleeding, and other complaints.
  • Arm II: Patients receive standard of care and undergo observation. After 12 months, patients may receive IRC ablation to all anal intraepithelial neoplasia lesions.

NOTE: Patients may receive a maximum of 6 IRC treatments while on study (3 per year).

Patients undergo a physical exam, digital rectal exam, anal cytology, and HRA at baseline and periodically during study.

After completion of study therapy, patients are followed up periodically for 2 years.

  Eligibility

Ages Eligible for Study:   27 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of high-grade anal intraepithelial neoplasia (AIN) meeting the following:

    • AIN2 and/or AIN3 confirmed by biopsy ≥ 2 weeks to ≤ 60 days before enrollment
    • 1-3 lesions with each lesion ≤ 15 mm in diameter
    • At least one high-grade AIN lesion is still visible at study entry
  • HIV-infection documented by federally approved, licensed HIV-test in conjunction with screening test (e.g., ELISA, western blot, or other test)

    • HIV-infection, based on prior ELISA and western blot assays, recorded and documented by another physician, allowed provided patient undergoes an approved antibody test to confirm diagnosis
    • Patients on concurrent anti-retroviral therapy with a history of HIV-positivity based on an approved antibody test allowed
    • Detectable plasma HIV-1 RNA also allowed
  • No perianal AIN, perianal condyloma, or lower vulvar intraepithelial neoplasia or condyloma requiring treatment

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 70-100%
  • Life expectancy ≥ 2 years
  • CD4 count ≥ 200/mm³
  • ANC > 750/mm³
  • Platelet count ≥ 75,000/mm³
  • Hemoglobin ≥ 9.0 g/dL
  • INR and aPTT normal
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Female patients must have undergone cervical pap smear (if having a cervix) and gynecologic evaluation within the past 12 months
  • Must be capable of complying with the requirements of this protocol
  • Concurrent HPV-related disease allowed
  • No history of anal cancer
  • No acute infection or other serious medical illness requiring treatment within the past 14 days

    • Fungal infection of the skin or a sexually transmitted disease requiring treatment allowed
  • No concurrent malignancy requiring systemic therapy

    • Kaposi sarcoma limited to the skin allowed

PRIOR CONCURRENT THERAPY:

  • No prior infrared coagulator (IRC) ablation for high-grade anal intraepithelial neoplasia (HGAIN)

    • Prior HGAIN treated by any means other than IRC within the past 2 months allowed
  • At least 5 days since prior coumadin or clopidogrel and ≥ 7 days after study therapy before receiving coumadin or clopidogrel again
  • No concurrent anticoagulant therapy other than aspirin or NSAIDs
  • More than 3 months since prior and concurrent systemic corticosteroids, cytokines, or immunomodulatory therapy (e.g., interferons) or local imiquimod
  • No concurrent systemic therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01164722

Locations
United States, California
UCLA Clinical AIDS Research and Education (CARE) Center
Los Angeles, California, United States, 90095-1793
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94143
United States, Massachusetts
Boston University Cancer Research Center
Boston, Massachusetts, United States, 02118
United States, New York
Laser Surgery Care
New York, New York, United States, 10010
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States, 10021
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Washington
Benaroya Research Institute at Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Sponsors and Collaborators
AIDS Malignancy Clinical Trials Consortium
Investigators
Principal Investigator: Stephen E. Goldstone, MD Laser Surgery Care
  More Information

Additional Information:
No publications provided

Responsible Party: AIDS Malignancy Clinical Trials Consortium
ClinicalTrials.gov Identifier: NCT01164722     History of Changes
Other Study ID Numbers: AMC-076, U01CA121947, AMC-076
Study First Received: July 16, 2010
Last Updated: July 8, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by AIDS Malignancy Clinical Trials Consortium:
anal cancer
HIV infection
human papilloma virus infection
neoplasm of uncertain malignant potential
high-grade squamous intraepithelial lesion

Additional relevant MeSH terms:
Anus Neoplasms
Neoplasms
Precancerous Conditions
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anus Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on July 24, 2014